Verification, validation, qualification

As a maker or supplier in a regulated market environment, you have to comply with a wide range of legal requirements. And that’s a good thing. Because your paramount aim is to guarantee your products’ quality and safety, and thus protect the user. HEITEC can assist and support you in meeting regulatory requirements with a comprehensive approach – from advising and training your employees to design, planning, implementation and execution.

Our experienced employees have specific expertise in their particular industries, and will support you in every phase of validation. Their consistently risk-based approach takes all contingencies into account, thus ensuring high standards. And it also enables us to ensure that projects advance efficiently and meet compliance guidelines. 

Meeting regulatory requirements promptly 

1

Design and planning

  • User specifications
  • Risk analyses
  • Functional specifications
  • System design specifications
  • Detailed specifications for hardware and software configuration
2

Implementation in conformity with Good Manufacturing Practices (GMP)

  • Certified quality management system (9001 13485)
  • Compliance with 21 CFR Part 11, Annex 11, Annex 15
  • GAMP 5 guideline
3

Verification (testing)

  • Installation and system setup (IQ)
  • System functioning (OQ)
  • Measuring equipment and process capability studies
  • Software validation
  • Cleaning and sterilization validation